跳至主要内容
临床试验/NCT02937194
NCT02937194已完成不适用

Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
580
试验地点
1
主要终点
Parental Toothbrushing on Infants

研究概览

简要总结

Early childhood caries (ECC) is a global health problem that causes pain and infection to the children affected. It is a common disease among preschool children in Hong Kong. There is a great need to improve at-home ECC preventive measures through oral health promotional activities as early as possible to parents.

The investigators will propose a 4-year randomized controlled trial of family-centered oral health promotion for new parents which aims to increase the proportion of parents brushing their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the transfer of MS from the parents to their infants and then reducing the risk of ECC of the children at 3 years. The investigators also aim to improve the oral hygiene status of the new parents and prevention of oral diseases among themselves.

First-time expectant mothers and their husbands will be recruited. The recruited families will be randomly allocated to the test and control groups. In the test group, personal hygiene instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before the delivery of the new born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive data will be collected from the mothers, fathers and the infants in both the test and control groups at different time points through dental examination, biological testing and questionnaire survey. The CONSORT statement will be strictly followed when conducting the clinical trial, analyzing the data and reporting the results.

It is anticipated that the effectiveness of oral health promotion starting at the pregnancy period and for both expecting mothers and their husbands will be greater in preventing the infants from developing ECC. Furthermore, establishing good oral health care habits will have long term benefits, helping safeguard the oral health of the children as they grow and the family as a whole. This study will also provide much needed evidence for the further development of oral health policies and oral health promotion programmes in Hong Kong; specifically how these can be integrated into family health education so as to achieve a higher effectiveness. This will contribute significantly to the improvement of oral health in the population of Hong Kong.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • First-time pregnancy
  • Of Chinese ethnicity
  • Ability to speak Cantonese and read traditional Chinese

排除标准

  • Pregnant women with any communication difficulties noted
  • Informed consent not obtained

结局指标

主要结局

Parental Toothbrushing on Infants

时间窗: 12 months

Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months

Early Childhood Caries (ECC)

时间窗: 36 months

Prevalence of early childhood caries (ECC) among study children at 36 months

次要结局

  • Feeding Habits on Infants(12 months)
  • Mothers' Gingival Bleeding(12 months)
  • Ratio of Mutans Streptococci (MS)(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor May C.M. Wong

Professor

The University of Hong Kong

研究点 (1)

Loading locations...

相似试验